Impact of Steatotic Liver Disease Associated With Metabolic Dysfunction (MASLD) on Frailty, Cognition, and Quality of Life. A Gender-sensitive Approach Towards a Comprehensive and Equitable Perspective.

NCT07652892 | Recruiting

• 1 other identifier: IIBSP-MAS-2025-133
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to determine the differences in the prevalence, characteristics and evolution of frailty between men and women diagnosed with MASLD, and to establish its relationship with clinical, functional, hormonal and social parameters.

Conditions

Steatosis of Liver

Keywords

A condition characterized by the accumulation of fat in the liver, which is closely linked to metabolic disorders and occurs with low or no alcohol consumption.

Outcome Measures

Primary Outcomes (2)

• Change in Liver Frailty Index (LFI) score

  Change in Liver Frailty Index (LFI) score from baseline to follow-up. Higher values indicate worsening frailty, whereas lower values indicate improvement in frailty.

  Baseline to Month 12

• Fried Frailty Index

  The Fried Frailty Index assesses frailty based on five components: unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity. Higher scores indicate greater frailty. Positive change scores indicate worsening frailty, whereas negative change scores indicate improvement.

  Baseline to Month 12

Secondary Outcomes (8)

• Association Between Frailty and Functional Performance Measures

  Baseline to Month 12

• Association Between Frailty and Inflammatory, Metabolic, and Oxidative Stress Biomarkers

  Baseline to Month 12.

• Association Between Frailty and Hormonal Parameters

  Baseline to Month 12

• Association Between Frailty and Body Composition

  Baseline to Month 12

• Association Between Frailty and Gut Microbiota Composition

  Baseline to Month 12

Study Arms (1)

Patients diagnosed with MASLD

Consecutive patients diagnosed with MASLD at any degree of fibrosis between the ages of 20 and 80 will be included. The main variable will be the degree of frailty assessed by the LFI and the Fried Index.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The degree of frailty will be compared between patients with MASLD and a cohort of individuals without liver disease. For this purpose, we have a historical cohort of 135 individuals without liver disease from primary care clinics whose frailty was assessed using the Fried frailty index. From this cohort, we will select participants by matching sex and age with the MASLD patients recruited for the present study.

You may qualify if:

• Patients will be included who are able to provide informed consent and actively participate in periodic assessments.

You may not qualify if:

• Risky alcohol consumption:
• \> 30 g/day in men and \> 20 g/day in women. AUDIT score: \> 7 points in men, \> 5 in women.
• Other liver diseases (viral hepatitis, autoimmune hepatitis, etc.).
• Advanced neurodegenerative diseases or severe psychiatric disorders.
• Severe comorbidities or treatments that, in the researchers' judgment, may affect frailty and quality of life more than metabolic syndrome and liver disease.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (2)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08031, Spain

NOT YET RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08031, Spain

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Eva Roman

  Institut de Recerca IR Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Román, Digestive Pathology Nurse

CONTACT

0034630818580; ERoman@santpau.cat

German Soriano, Digestive Pathology MD

CONTACT

gsoriano@santpau.cat

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 17, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): May 25, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

ES (2)